The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease.

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Mean Difference in Non-HDL Cholesterol Level Changes Between Patients Assigned to Stay Compared to Patients Assigned to Switch at the Last Observation [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day

Drug: Aripiprazole

Switching medication to aripiprazole for schizophrenia for up to 6 months in study

Other Name: Abilify

Active Comparator: 2

Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.

Drug: Risperidone

Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study

Other Name: Risperdal

Drug: Olanzapine

Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study

Other Name: Zyprexa

Drug: Quetiapine

Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study

Other Name: Seroquel

Detailed Description:

Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls. Although there is some evidence that patients with schizophrenia have intrinsic abnormalities in lipid and carbohydrate metabolism, some antipsychotics (i.e., clozapine, olanzapine, quetiapine, and risperidone) are associated with increased rates of metabolic abnormalities that predispose patients to cardiovascular disease.

This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network.

The aims of the study are to (1) determine the relative effects of switching to aripiprazole, versus continued treatment with olanzapine, quetiapine, or risperidone, on metabolic parameters associated with cardiovascular disease, and (2) to determine the effects of switching to aripiprazole versus continued treatment with olanzapine, quetiapine, or risperidone on the clinical stability of schizophrenic illness.

This study design is a multi-site, single-blind (rater) randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications: olanzapine, quetiapine, risperidone, and aripiprazole. The study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication. Patients who are taking olanzapine, quetiapine, or risperidone and who have a body-mass index (BMI) greater than or equal to 27 and non-HDL cholesterol greater than or equal to 130 mg/dl will be eligible (if non-HDL is between 130-139mg/dL, LDL cholesterol must be greater than 100mg/dL). All treatments will be open label. Raters will be blinded to treatment assignment. Patients will be followed for up to 6 months.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosed with schizophrenia or schizoaffective disorder

Currently treated with olanzapine, quetiapine or risperidone

BMI greater than or equal to 27

Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is between 130 - 139 mg/dL, then LDL cholesterol must be greater than 100 mg/dL).

Exclusion Criteria:

Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin

Non-HDL cholesterol greater than 300 mg/dL

Serum triglycerides greater than 500 mg/dL

Patients in the first episode of schizophrenia or schizoaffective disorder

Known hypersensitivity to aripiprazole

On weight loss medications

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423878